Dec. 2, 2019 – In its sixth Untitled Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) cited Nascent Biotech Inc. for promoting an investigational new drug (IND) as a safe and effective treatment for brain cancer on its website. This is the second enforcement letter in 2019 to address issues related to […]
Read more Sept. 9, 2019 – In its first Warning Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP), continues to call out the omission of risk information cited in previous Untitled Letters this year, stating that Metuchen Pharmaceuticals LLC’s direct-to-consumer (DTC) print ad and display banners for its erectile dysfunction (ED) drug include claims […]
Read more Aug. 5, 2019 – In two new Untitled Letters, the FDA’s Office of Prescription Drug Promotion (OPDP) makes clear that omitting risk information, misrepresenting product efficacy and using visuals that distract from risk messaging in direct-to-consumer (DTC) broadcast ads may draw the agency’s enforcement attention. In a July 25 Untitled Letter to CooperSurgical Inc., OPDP […]
Read more June 19, 2019 – The FDA’s Office of Prescription Drug Promotion (OPDP) has cited VIVUS Inc. for making false or misleading claims about the efficacy of and risks associated with Qsymia capsules, which are intended to be an adjunct treatment for obesity with a reduced-calorie diet and increased exercise, but allegedly were promoted as being […]
Read more April 30, 2019 – In its first enforcement letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) asserts that an article posted on a sponsor’s website misbrands the investigational drug “Sodium Acetate C-11” (11-C Acetate) because it suggests in a promotional context that the drug is safe and effective for the purpose for […]
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Nov. 2, 2018 – Providing information about a drug product’s benefits without including any risks is an issue that the FDA’s Office of Prescription Drug Promotion (OPDP) does not take lightly, as evidenced by an Oct. 22 Warning Letter from OPDP to Vanda Pharmaceuticals Inc. This Warning Letter is the second Warning Letter issued in […]
Read more Oct. 19, 2018 — The FDA’s Office of Prescription Drug Promotion (OPDP) issued two enforcement actions in less than a week that focused on alleged safety and risk information infractions for products with Boxed Warnings; both matters were brought to the agency’s attention through OPDP’s Bad Ad program. “These letters are significant not because they […]
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